Study on Adding Triapine to Standard Chemotherapy and Radiation for Advanced Cervical and Vaginal Cancers
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02466971
This clinical trial is testing whether adding a new drug, Triapine, to the usual chemotherapy and radiation treatment can improve outcomes for patients with advanced cervical and vaginal cancers.
Patient Parameters
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Program Overview
This study is exploring if adding Triapine to the standard treatment of chemotherapy (using cisplatin) and radiation can better treat patients with advanced cervical and vaginal cancers. Radiation therapy uses high-energy particles to kill cancer cells, while cisplatin helps stop cancer cells from growing and spreading. Triapine may help by blocking certain enzymes that cancer cells need to grow. The study aims to find out if this combination is more effective than the standard treatment alone.
Description
The main goal of this study is to see if adding Triapine to the usual treatment of cisplatin and radiation can help patients with cervical or vaginal cancer live longer. Researchers also want to see if this combination can prevent the cancer from coming back or getting worse.
The study will also look at the side effects of the treatments and compare them between different types of radiation therapy. Patients will be randomly assigned to one of two groups:
- Group 1: Receives cisplatin and radiation therapy.
- Group 2: Receives cisplatin, radiation therapy, and Triapine.
Patients will receive treatment over several weeks and will be monitored for any side effects. After completing the treatment, patients will have follow-up visits to check their health and the effectiveness of the treatment.
The study will also explore new ways to plan and deliver radiation therapy to improve outcomes and reduce side effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced cervical or vaginal cancer that cannot be treated with surgery alone.
- Able to undergo imaging tests required for the study.
- Provide informed consent to participate in the study.
- Have a performance status that allows for daily activities with some limitations.
- Meet specific blood count and organ function requirements.
- Not have uncontrolled diabetes or other serious health conditions.
- Not have known brain metastases or HIV.
- Not be allergic to Triapine or similar drugs.
- Not have a condition that affects Triapine metabolism.
- Not be breastfeeding or willing to stop before treatment.
Exclusion Criteria
- Have another active cancer.
- Have had another invasive cancer diagnosed within the last three years, except for certain skin cancers or cervical cancer treated with surgery.
- Have serious health conditions like heart disease or lung disease that are not well-controlled.
- Be pregnant or not agree to use birth control if of childbearing potential.
- Have had a hysterectomy or plan to have one after radiation.
- Plan to receive additional chemotherapy after the standard treatment.
- Have a known deficiency that affects Triapine metabolism.
- Have had a hysterectomy for cervical cancer less than five years ago if diagnosed with vaginal cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
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